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ARCHIVED - Janssen Covid vaccine begins phase III of its trials in Spain
Nine hospitals will participate in this third phase of trials
The Spanish Agency for Medicines and Health Products (AEMPS) has authorized the first phase III clinical trial for the Janssen vaccine against Covid-19, manufactured by the company Janssen, belonging to the multinational Johnson & Johnson.
This is the first phase III trial of this type authorized in Spain.
The trials of phase 2 of this vaccine received a flood of volunteers in Spain in September, and 190 people were selected to receive the first doses on September 14th. The Madrid hospitals of La Paz and La Princesa, together with the Hospital Marqués de Valdecilla in Santander, were the three centers which participated in the second phase of the clinical trial, which seeks to find the most appropriate dose and regimen to achieve the best antibody response. The second phase of the research, sought to evaluate which is the most appropriate dose and schedule in terms of activity to achieve the best antibody response (those that generate immunity against the virus), as well as to continue evaluating safety of the product under investigation. In phase III the trial will be extended to a total of nine hospitals throughout Spain.
The phase 3, multicenter and multinational clinical trials will be necessary to demonstrate that the selected dose is safe and effective in preventing coronavirus infection.
This is a randomized clinical trial in which different branches of treatment will be analyzed. In all cases, two vaccinations will be carried out in each patient, so that some patients will only receive a placebo, others one dose and others two doses of the product under investigation.
Furthermore, it is a double-blind trial in order to prevent that the results may be influenced by the placebo effect or by observer bias.
The follow-up of the patients will be carried out through several visits to the center, from the initial screening. After a first vaccination, a diary is given to the participants where they must note any adverse effects and the temperature recorded daily and go to the center weekly for the pertinent controls. After the second dose, visits as well as control calls and safety analyzes will be carried out.
The vaccine will be tested on a total of 30,000 volunteers from nine countries, including Belgium, Colombia, France, Germany, the Philippines, South Africa, Spain, the United Kingdom and the United States.
The need to find vaccines is becoming increasingly important as the world becomes “covid weary” and governments struggle to maintain lockdowns and restrictions against a growing wave of opposition from businesses forced to close and a general public bored with having to make sacrifices in their lifestyle in order to save the lives of those most vulnerable to the virus.
During the summer this pressure resulted in governments relaxing restrictions in order to allow the public to enjoy their summer holidays and for the hostelry sector to earn some money, the result being the wave of deaths currently being experienced all over Europe as the virus spread like wildfire throughout dozens of countries unchecked. Now the pressure is increasing for our governments to bring the virus under control so we can all enjoy our Christmas celebrations with friends and family; with the threat of the forthcoming flu season co-inciding with the festive season, yet again we face the risk that with the pressure eased off for Christmas, that in January and February restrictions will be necessary yet again as the price we pay for a week of festivities if the virus is not brought fully under control by the time restrictions are relaxed.
Although we all WANT this to be over as quickly as possible, the chances of that actually happening until these vaccines start to do their work is fairly remote, given the virulence of the virus and the unwillingness of the general public to go without a beer in a bar for the time period required to fully bring case numbers down.
Here in Spain, the Ministry of Health reported 435 deaths from COVID-19 on Tuesday, which represents a new maximum during the second wave and raises the death toll to 41,688. 13,159 new cases of coronavirus were also reported, taking the number of cases diagnosed in Spain past one and a half million to reach 1,510,023.
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